Alzheimer's Disease
Conditions
Keywords
Lu AE58054
Brief summary
To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)
Interventions
DRUGIdalopirdine
Idalopirdine 60-120 mg daily dose
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria. * The patient has had a positive amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD. * The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 22. * The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient. * The patient is a man or woman of at least 50 years of age and has a body mass index (BMI) ≥ 18.5 kg/m2.
Exclusion criteria
* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results. * The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-HT6 Receptor Occupancy (RO) | Treatment day 10 (24 hours post dose) | RO in the region of interest will be calculated as 100 × (1 - BPND(treatment) / BPND(baseline)) where BPND is the binding potential |
| Idalopirdine plasma concentration (CPET) | Prior to and after PET scan on treatment day 10 | CPET is the concentration at the time of PET scan, defined as (CprePET + CpostPET) / 2 (average of the pre- and post-PET scanning measurements). |
Countries
United States
Outcome results
None listed